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Concept Mapping as a Scalable Method for Identifying Patient-Important Outcomes (VOICe)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2016 by Thomas Jefferson University
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT02792777
First received: June 2, 2016
Last updated: June 8, 2016
Last verified: June 2016
  Purpose
The goal of this study is to improve the methods with which researchers identify patient centered outcomes for use in research. Specifically, the investigators will test the application of concept mapping as compared to one-on-one interviews as a comprehensive and efficient method of identifying patient-important outcomes for use in research.

Condition Intervention
Concept Mapping Versus Interviews Other: Interviews Other: Concept Mapping (CM)

Study Type: Observational
Study Design: Time Perspective: Prospective

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Comparison of methods in terms of comprehensiveness [ Time Frame: 01/2018-01/2019 ]

    First, the investigators will determine the proportion of outcome themes identified in each interview settings that are present in 1) the list of outcome clusters generated from the initial concept mapping session and 2) an aggregate list of outcome clusters from all three concept mapping sessions. The investigators will also identify the presence of additional outcomes clusters in the concept mapping groups that were not identified in interviews.

    Then the investigators will measure the comprehensiveness of outcomes as elicited in one concept mapping session compared to multiple sessions. The investigators will assess "concept mapping saturation," wherein we compare the cluster themes that emerge from each CM group. The investigators will use the outcomes from our first group as the "baseline data," and will determine the amount of new data added from including a second/third group. This assessment will allow us to draw a basic "concept mapping saturation curve."



Secondary Outcome Measures:
  • Comparison of methods in terms of efficiency [ Time Frame: 01/2018-01/2019 ]
    The investigators will assess the efficiency of implementation of the two methods, with efficiency including primarily measures of overall time of researchers, patient-partners, and patient-participants required for method completion. The investigators will compare the efficiency of conducting one concept mapping iteration to the efficiency of performing one set of interviews done to theme saturation. The efficiency of each method will be assessed by measuring overall resource utilization for conducting that method. Then, they will determine the resource intensiveness for completion of a single concept mapping iteration through to completion, and for one set of interviews performed to saturation. Collection of the data points will be performed during the design and implementation of Aim 1. This efficiency analysis is structured for what would need to be budgeted for in a grant application, and will provide useful information for general planning needs for method implementation.


Estimated Enrollment: 195
Study Start Date: January 2016
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Interviews
Interview participants will be recruited from 3 different care settings: an acute care visit (in the emergency department), a post-acute care visit (within 1 week of a hospital discharge), and a routine primary care visit. Target sample size within each healthcare setting is 30 patients, which is the anticipated number needed for thematic saturation. The total recruitment goal for this cohort is 90-120 participants.
Other: Interviews
Patients will be engaged in open-ended, semi-structured qualitative interviews, which will be performed one-on-one either in person or over the phone (depending on the healthcare setting that they are recruited from). Qualitative interviews will be audio recorded, with the patient's permission, transcribed, de-identified and entered into NVivo 10.0 software for coding and analysis.
Concept Mapping
Concept mapping participants will be recruited from existing clinical and research databases for 3 separate concept mapping groups, each with a target of 20 patients. The total recruitment goal for this cohort is 60 people.
Other: Concept Mapping (CM)

The CM process consists of 3 steps that take place over 3 sessions:

Step 1: Generation of Ideas- Participants brainstorm and generate responses to the focus statement. Once the group agrees that no new statements are being generated, the list of statements is reviewed within the group.

Step 2: Structuring of Statements- Each participant is given a set of sort cards and asked to sort the statements into piles. Participants then rate each idea regarding importance. Research staff enters this information into the CM software.

Concept Systems Global Software generates point maps using a technique that detects underlying similarities/differences between statements. The CM software then uses hierarchical cluster analysis to draw boundaries around the point map to create conceptual clusters.

Step 3: Interpretation- The CM group revises the concept map. Participants review the cluster names suggested by the software and decide upon final naming of each cluster as a group.


Detailed Description:

This is an observational study comparing two methods - concept mapping and one-on-one interviews. The investigators will test the methods themselves by comparing the comprehensiveness of the lists of patient-important outcomes obtained through each method (primary outcome) as well as the efficiency, as measured by resource intensiveness, of the methods (secondary outcome). The aims of this study will be tested with adult patients with moderately to poorly controlled diabetes mellitus who receive care at a large, urban, academic health system. In order to allow comparisons of the comprehensiveness of the methods in producing patient-important outcomes regardless of the healthcare setting in which outcomes are elicited, the investigators will recruit patients for the interview group from 3 different care settings: an acute care visit (in the emergency department), a post-acute care visit (within 1 week of a hospital discharge), and a routine primary care visit. Target sample size within each healthcare setting is 30 patients, which is the anticipated number needed for thematic saturation. The investigators will then recruit patient-participants from existing clinical and research databases for 3 separate concept mapping groups, each with a target of 20 patients. In Aim 2, the investigators will test the hypothesis that concept mapping in a research setting produces outcomes consistent with those elicited from patients in the "real-world" settings. In Aim 3, the investigators will assess the overall resource utilization, assessed primarily by time required from patients, the research team, and the advisory board, of qualitative interviews conducted to thematic saturation within a single healthcare setting compared to resources used for a single iteration of concept mapping.

Findings from this work will improve patient-centered outcomes research methods by providing researchers with information about standardized scalable methods to identify patient-important outcomes for use in research studies, so that individual patients are able to select outcomes that are most useful to them. In addition to providing insight regarding methods for eliciting patient-centered outcomes, the study will also provide valuable information to stakeholders regarding how patients' priorities vary across the care continuum. The investigators will report how findings from concept mapping apply across healthcare settings, and the degree to which patient priorities (based on interviews) differ across healthcare settings. If concept mapping results (collected in the research setting) capture the priorities identified by patients across different healthcare settings, this finding would enhance researchers' ability to perform studies in different, or multiple, settings. If the findings do not generalize across settings, this will be a valuable finding demonstrating that patient priorities differ across interview settings and patient acuity and will validate researchers' needs to be specific about the setting in which they choose to perform research to ensure they are reaching their intended patient population.

The work is being performed in close collaboration with the Patient and Key Stakeholder Advisory Board (PAKSAB) - equal partners with the research team who have been involved with the proposal from inception. PAKSAB members will be part of the research team throughout conducting the aims and assisting with all analysis and data interpretation.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The investigators aim to engage a discrete population of patients who have recently sought care at Thomas Jefferson University for treatment needs related to moderately to poorly controlled diabetes. Consistent with the overall population served by Jefferson, the investigators expect greater than 50% of enrolled patients to be African American and approximately 30% of them to be at the <20% federal poverty line. All data will be collected prospectively. The investigators decided to engage patients with moderately to poorly controlled DM because these patients have a known high risk of severe complications related to poor diabetes control, and a significant proportion of patients remain poorly controlled despite available therapies. The investigators thus determined in discussion with the PAKSAB that this population is a good candidate for testing the method of concept mapping to identify patient-important outcomes.
Criteria

Inclusion Criteria:

  • Adult patient (age 18 and older)

    • English speaking
    • Provide informed consent
  • Diagnosis of moderately to poorly controlled diabetes mellitus (DM) defined as follows (for interview groups):

    • Acute care setting: patient in the Jefferson Emergency Department (ED) for a diabetes-related problem determined to require medical treatment
    • Post-acute care setting: patient was discharged from the Jefferson Family Medicine Associates (JFMA) hospital service within the past 7 days after admission for a diabetes-related problem
    • Primary care setting: patient currently attending a routine scheduled care visit (not urgent need) at the JFMA practice and has at least 2 measurements of HgbA1C > 7.5 in the prior one year
  • Diagnosis of moderately to poorly controlled diabetes mellitus (DM) defined as follows (for concept mapping groups):

    • Acute care setting: patient within the Jefferson ED patient contact database (see below) who has had a visit to the Jefferson ED over the past 6 months (as determined on chart review) for a diabetes-related problem
    • Post-acute care setting: patient was discharged from the JFMA hospital service within the past 6 months after admission for a diabetes-related problem
    • Primary care setting: patient has had routine scheduled office visit within the past 6 months to the JFMA practice and has at least 2 measurements of HgbA1C > 7.5 in the prior one year

Exclusion Criteria:

  • Patient has had a significant permanent complication related to DM including:

    • End stage renal disease
    • History of amputation
    • Blindness related to diabetes complication
  • Patient undergoing medical clearance for a detox center or any involuntary court or magistrate order
  • Patient in police custody or currently incarcerated individual
  • Patient who has, in their clinician's best judgment, major communication barriers such as visual or hearing impairment or dementia that would compromise their ability to give written informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02792777

Locations
United States, Pennsylvania
ThomasJeffersonU Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Melissa McCarey    215-503-7417    Melissa.McCarey@jefferson.edu   
Principal Investigator: Kristin L Rising, MD, MS         
Principal Investigator: Marianna LaNoue, PhD         
Sponsors and Collaborators
Thomas Jefferson University
Patient-Centered Outcomes Research Institute
  More Information

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02792777     History of Changes
Other Study ID Numbers: 15G.667
Study First Received: June 2, 2016
Last Updated: June 8, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Thomas Jefferson University:
Concept Mapping
VOICe
Interviews
Patient-Centered Research

ClinicalTrials.gov processed this record on September 21, 2017